"0406-8955-01" National Drug Code (NDC)

Mixed Salts Of A Single Entity Amphetamine Product 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8955-01)
(SpecGx LLC)

NDC Code0406-8955-01
Package Description100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8955-01)
Product NDC0406-8955
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMixed Salts Of A Single Entity Amphetamine Product
Proprietary Name SuffixXr
Non-Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20190422
Marketing Category NameANDA
Application NumberANDA211547
ManufacturerSpecGx LLC
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength6.25; 6.25; 6.25; 6.25
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA ScheduleCII

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